A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan

Novartis Pharmaceuticals754 enrolled

Overview

The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan. This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.

Study Type

OBSERVATIONAL

Enrollment

754

Conditions

Myeloid Leukemia, Chronic

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Patients who met all the below inclusion criteria and none of the exclusion criteria were included in the study. Inclusion criteria: * Patients who had at least one TKI prescription during the selection period, * a confirmed diagnosis of chronic phase CML recorded before or at the index date, * were aged 15 years or older at the index date, and * had at least 12-months continuous pre-index period. Exclusion criteria: * Patients who had at least one TKI prescription in the 12 months preceding the index date (washout period to catch the 1st line of treatment \[LoT\]), * a confirmed diagnosis of CML blast crisis or accelerated phase recorded prior to, at, or within 6 months after the index date, * a confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) within 6 months after the index date, * a medical record of chemotherapy (not including hydroxyurea) within 6 months after the index date, * a stem cell transplant procedure recorded during the pre-index period.

Outcomes

Primary Outcomes

Number of Patients by Line of Treatment (LoT) and TKI Received

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Up to approximately 9 years

Number of Patients who Switched TKI Treatment by LoT and TKI

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Up to approximately 9 years

Number of Patients who Discontinued TKI Treatment by Type of TKI

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Up to approximately 9 years

Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Up to approximately 9 years

Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Up to approximately 9 years

TKI Dose by LoT

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Baseline, up to approximately 9 years

TKI Persistence Rate by LoT

Time frame: Months 6, 12, 18, and Year 5

Duration of TKI Treatment by LoT

Time frame: Up to approximately 9 years

Secondary Outcomes

Annual Incidence of Inpatient and Outpatient Visits by LoT

Time frame: Up to approximately 9 years

Annual Mean Cost of All-cause Healthcare Resource Use by LoT

All-cause care included inpatient and outpatient visits. The following costs were calculated in Japanese yen (JPN): * Total costs * Inpatient costs * Outpatient costs * Pharmacy costs

Time frame: Up to approximately 9 years

Annual Incidence of CML-related Healthcare Resource Use by LoT

CML-related care included: * Major BCR-ABL1 procedures (diagnostic and response to treatment testing) * Complete blood count testing - peripheral blood general testing * Hematological examination diagnosis fee * TKI prescriptions

Time frame: Up to approximately 9 years

Annual Mean Cost of CML-related Healthcare Resource Use by LoT

CML-related care costs were calculated in Japanese Yen (JPY) and included the following: * Total CML-related costs * Major BCR-ABL1 procedure costs * Complete blood count testing - peripheral blood general testing costs * Hematological examination costs * TKI prescription costs

Time frame: Up to approximately 9 years

Number of Patients With Adverse Events by TKI

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Time frame: Up to approximately 9 years

A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes